BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BOOMERANG CATALYST SYSTEM

    MDR report key: 1013120 · Received March 14, 2008

    Report

    Report Number
    3004182619-2008-00007
    Event Type
    Injury
    Date Received
    March 14, 2008
    Date of Event
    October 16, 2007
    Report Date
    February 26, 2008
    Manufacturer
    CARDIVA MEDICAL, INC.
    Product Code
    MGB
    PMA / PMN Number
    K070485
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE BOOMERANG CATALYST WIRE WAS DISCARDED AT THE HOSPITAL AND WAS NOT BE RETURNED TO THE MANUFACTURER FOR EVALUATION. IT WAS REPORTED THE PRODUCT PERFORMED AS INTENDED PER IFU. THE BCW PROVIDED TEMPORARY HEMOSTASIS. REVIEW OF THE DEVICE HISTORY LOT RECORD COULD NOT BE PERFORMED BECAUSE THE LOT NUMBER WAS NOT AVAILABLE. THE PHYSICIAN INVOLVED STATED THE BOOMERANG DID NOT CAUSE OR CONTRIBUTE TO THE INCIDENT. CORDIS INTRODUCER KIT AND SHEATH WERE USED TO CREATE AN OPENING (ARTERIOTOMY) IN RCFA; MANUAL COMPRESSION WAS METHOD USED TO ACHIEVE HEMOSTASIS (CLOSE) OF THE OPENING MANUAL COMPRESSION WAS UNABLE TO CLOSE MULTIPLE VESSEL PUNCTURES. MULTIPLE PUNCTURES ARE A CONTRAINDICATION TO USING THE BOOMERANG WIRE AS PART OF THE IFU.

    Description of Event or Problem · 1

    A DIAGNOSTIC PERIPHERAL PROCEDURE WAS PERFORMED IN 2007 ON A FEMALE PATIENT. A 5 FR CORDIS 11 CM SHEATH WAS PLACED IN THE RIGHT COMMON FEMORAL ARTERY (RCFA) AND ASA AND PLAVIX WAS ADMINISTERED. UPON COMPLETION OF THE PROCEDURE, A BOOMERANG CATALYST WIRE (BCW) WAS INSERTED AND DEPLOYED THROUGH THE INDWELLING SHEATH WITHOUT PROBLEM. TEMPORARY TAMPONADE OF THE ARTERIAL ACCESS SITE WAS SUCCESSFULLY ACHIEVED; EVIDENCED BY NO OOZING OR HEMATOMA NOTED. THE BCW WAS REMOVED WITHOUT PROBLEM, PERFORMING SUCCESSFULLY AS INDICATED; THEN MANUAL COMPRESSION BY SANDBAG WAS APPLIED TO THE ARTERIOTOMY SITE UNTIL HEMOSTASIS WAS ACHIEVED. PT WAS TRANSFERRED TO RECOVERY. AT 90 MINUTES POST REMOVAL, A HEMATOMA STARTED TO FORM AND WAS DIAGNOSED TO BE A PSEUDOANEURYSM UNDER US. APPARENTLY, THERE WERE MULTIPLE PUNCTURE SITES: SIDE WALL BRANCH AND PERFORATION BELOW THE INGUINAL LIGAMENT. PT WAS TRANSFERRED TO OR AND VASCULAR SURGERY WAS PERFORMED TO REPAIR THE ARTERY. PT RECOVERED AND WAS DISCHARGED WITHOUT SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOOMERANG CATALYST SYSTEM VASCULAR CLAMP MGB CARDIVA MEDICAL, INC. 400-580P UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R 5 FR CORDIS 11CM SHEATH